Long Pulmonary Residence Time and Plasma Half-Life of Tiotropium: Implications for Pharmacokinetic Bioequivalence Studies
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Tiotropium bromide is a once-daily, inhaled long-acting anti-muscarinic bronchodilator that has attained a central role in the management of chronic obstructive pulmonary disease . It is available under the trade name Spiriva® in two formulations manufactured by the drug innovator, Boehringer Ingelheim: an aqueous solution delivered via the Respimat® soft-mist inhaler, and a dry powder (18 µg of tiotropium per capsule) delivered by the HandiHaler® device. Recently, another tiotropium bromide-containing product (13 µg of tiotropium per capsule) administered by the Zonda® dry powder inhaler received regulatory approval in Europe via the decentralized procedure . A clinical trial claiming to demonstrate pharmacokinetic bioequivalence between this product and the Boehringer Ingelheim originator product was recently published in this journal by Algorta et al. .
The purpose of this letter is to dispute two claims made by Algorta et al. , namely (1) that their...
The authors acknowledge the medical writing support of Dr. Paul Tanswell.
Compliance with Ethical Standards
This study was funded by Boehringer Ingelheim.
Conflict of interest
Ashish Sharma and Benjamin Weber are employees of Boehringer Ingelheim Pharmaceuticals. Bernd Meibohm has consulted for Boehringer Ingelheim Pharmaceuticals.
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